PROTOCOL REVIEW & MONITORING SYSTEM: SUMMARY The Hollings Cancer Center (HCC) Protocol Review & Monitoring System (PRMS) oversees and provides in- dependent, peer review of the scientific merit, priority, and progress of all prospective, hypothesis-driven, can- cer studies involving human subjects conducted at the Medical University of South Carolina (MUSC). PRMS functions are accomplished by rigorous review in a two-stage process conducted by: 1) HCC Clinical Disease Focus Groups (DFG), where initial assessment of value, fit, and prioritization within the existing portfolio of studies is performed, as well as regular assessments of each study?s overall performance in terms of accrual; and 2) the Protocol Review Committee (PRC), which is the final definitive authority for determining which stud- ies proceed to activation and which studies remain activated based on scientific and accrual progress. The PRC is charged with ensuring that all prospective, hypothesis-driven, cancer research studies involving human subjects are: 1) scientifically sound; 2) effectively designed, specifically from a biostatistics perspective; 3) ap- propriately prioritized within each DFG?s research portfolio to avoid competing trials, as well as aligned with the HCC?s overall institutional priorities for clinical research; 4) feasible for completion or in meeting institutional accrual goals; 5) assessed for the adequacy of the data and safety monitoring plans based on the risk level of the study; and 6) monitored regularly for scientific and accrual progress. In 2017, the HCC DFGs vetted in ag- gregate 136 new studies and forwarded 102 (75%) of these studies to PRC review. Among the 102 studies received by the PRC, 37 studies (36%) received an initial expedited review by the PRC chair or co-chairs, as they had already received an appropriate external scientific peer-review, and 65 studies (64%), primarily repre- senting HCC?s investigator-initiated and industry-sponsored trials, were forwarded for full PRC review. Thirty- six of the 65 studies (55%) reviewed by the full PRC required modifications prior to being approved, and one study was disapproved and not allowed to proceed through the activation process. In addition, the PRC also conducted scientific and accrual progress reviews for all actively accruing HCC studies (330 studies) for which 27 underperforming studies were closed by the PRC in 2017. The HCC PRMS, inclusive of the DFGs and PRC review processes, is one of the most critical functions that the HCC performs to ensure the highest quality of research is being conducted at the HCC.